Details for New Drug Application (NDA): 074738
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NDA 074738 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage Pharms, Indoco, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Zydus Lifesciences, Abbvie, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Mylan Labs Ltd, and Teva Parenteral, and is included in eighty-eight NDAs. It is available from sixty-seven suppliers. Additional details are available on the ACYCLOVIR profile page.
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 074738
| Tradename: | ACYCLOVIR |
| Applicant: | Actavis Mid Atlantic |
| Ingredient: | acyclovir |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074738
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074738
Suppliers and Packaging for NDA: 074738
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | acyclovir | SUSPENSION;ORAL | 074738 | ANDA | Actavis Pharma, Inc. | 0472-0082 | 0472-0082-16 | 473 mL in 1 BOTTLE (0472-0082-16) |
| ACYCLOVIR | acyclovir | SUSPENSION;ORAL | 074738 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0083 | 17856-0083-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | Apr 28, 1997 | TE: | AB | RLD: | No | ||||
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